Treatment of vulvovaginitis with spirostanol enriched extract from Tribulus Terrestris

Abstract

Therapeutic compositions made from the herb Tribulus terrestris and methods of making and using the same are provided. The therapeutic compositions include an enriched extract having an increased spirostanol saponin content that is prepared from the harvested Tribulus terrestris L. The enriched extract is prepared using discrete hydrolysis, separation and enrichment steps. The resulting therapeutic may be combined with a cream base and is useful for treating bacterial, fungal, and viral infections, particularly gynecologic infections. This product was also found to be very successful in suppository form for the treatment of vulvo-vaginal, vulvo-hemorrhoidal and colonic conditions.

1 . A therapeutic composition for treating vulvovaginitis in a patient in need thereof said therapeutic composition comprising: 
 an aqueous extract of  Tribulus terristris  L.    
     
     
         2 . The composition of  claim 1 , wherein the  Tribulus terrestris  L comprises a first  Tribulus terrestris  L. extract and wherein the first  Tribulus terrestris  L. extract is treated to convert furostanol saponin compounds contained therein to spirostanol compounds.  
     
     
         3 . The composition of  claim 2 , wherein the first extract is subjected to a step that cleaves furostanol compounds contained in the first extract to form spirostanol compounds.  
     
     
         4 . The composition of  claim 3 , wherein the spirostanol compounds are isolated from a remaining portion of the first extract and are added to a second  Tribulus terrestris  L. extract to form an enriched extract.  
     
     
         5 . The composition of  claim 4 , wherein the spirostanol compounds are isolated from a remaining portion of the first extract by a method selected from the group consisting of chromatographic methods and micro-filtration methods.  
     
     
         6 . The composition of  claim 2 , wherein the percentage by weight of spirostanol compounds in the enriched extract is from approximately 0.1% to approximately 100%.  
     
     
         7 . The composition of  claim 6 , wherein the percentage of spirostanol compounds in the enriched extract is from approximately 20% to approximately 100%.  
     
     
         8 . The composition of  claim 7 , wherein the percentage of spirostanol compounds in the enriched extract is from approximately 50% to approximately 80%.  
     
     
         9 . The composition of  claim 2  comprising: 
 a. from about 70% to about 90% by weight of  Tribulus terrestris  L enriched extract;    b. from about 1% to about 4% of a humectant;    c. from about 0.15% to about 2% of a preservative;    d. from about 0.1% to about 1% of a sequestering agent;    e. from about 1% to about 5% of an agent selected from the group consisting of thickening agents, suspension agents and stabilizing agents;    f. from about 1% to about 4% of a softening agent; and    g. from about 0. 1% to about 1% of a solvent.    
     
     
         10 . The composition of  claim 9  wherein the humectant comprises glycerin.  
     
     
         11 . The composition of  claim 9 , wherein the softening agent comprises stearic acid.  
     
     
         12 . The composition of  claim 9 , wherein the solvent comprises triethanolamine.  
     
     
         13 . The composition of  claim 9 , wherein the sequestering agent comprises ethylenediamine tetraacetic acid.  
     
     
         14 . (canceled)  
     
     
         15 . (canceled)  
     
     
         16 . (canceled)  
     
     
         17 . (canceled)  
     
     
         18 . (canceled)  
     
     
         19 . (canceled)  
     
     
         20 . The method of  claim 4  wherein the topical the therapeutic composition comprises from about 5% to about 10% of the enriched extract.  
     
     
         21 . (canceled)  
     
     
         22 . (canceled)  
     
     
         23 . A method to treat an area of the skin affected by acne, comprising the steps: 
 a. preparing an aqueous first extract of  Tribulus terrestris  L;    b. treating the first extract to convert the furostanol saponin compounds contained therein to spirostanol compounds;    c. isolating the spirostanol compounds from the first extract;    d. adding the isolated spirostanol compounds to a second  Tribulus terrestris  L. extract to form an enriched extract;    e. adding the enriched extract to a base suitable for application to the skin to form a topical medication; and    f. applying the topical medication to the affected area.    
     
     
         24 . The method of  claim 23 , wherein the topical medication comprises between about 0.1% to about 100% of the enriched extract.  
     
     
         25 . A method of testing and preparing for readiness of harvesting  Tribulus terrestris  L. comprising the steps of: 
 a. collecting a sample of leaves, fruit and stems of  Tribulus terrestris  L;    b. adding about one part water to about 2.5 parts of the sample;    c. blending for about 15 minutes in a blender with sufficient speed to create a vortex;    d. immediately examining the level of foam and water in the blender; and    if there is at least 1.5 times as much foam as water, harvesting the  Tribulus terrestris  L. within the week, otherwise repeating steps a. through e. at a later time.    
     
     
         26 . The method of  claim 23 , wherein the spirostanol content of the enriched extract is from about 1% to about 70%.  
     
     
         27 . The method of  claim 26 , wherein the spirostanol content of the enriched extract is from about 5% to about 50%.  
     
     
         28 . A method to make a therapeutic composition for treating vulvovaginitis, comprising the steps of: 
 a. preparing a first extract of  Tribulus terrestris;      b. treating the first extract to convert furostanol saponin compounds contained therein to spirostanol compounds;    c. isolating the spirostanol compounds from the first extract;    d. adding the spirostanol compounds to a second aqueous/alcoholic  Tribulus terrestris  extract to form an enriched extract; and    e. adding the enriched extract to a pharmacologic base to form the therapeutic composition.    
     
     
         29 . The therapeutic composition of  claim 28 , comprising from about 0.1% to about 100% of the spirostanol compounds.  
     
     
         30 . The therapeutic composition of  claim 29  comprising from about 1% to about 70% of the spirostanol compounds.  
     
     
         31 . The therapeutic composition of  claim 30 , comprising from about 5% to about 50% of the spirostanol compounds.  
     
     
         32 . The therapeutic composition of  claim 31 , comprising from about 1% to about 100% of the enriched extract.  
     
     
         33 . The therapeutic composition of  claim 32 , comprising from about 5% to about 50% of the enriched extract.  
     
     
         34 . The therapeutic composition of  claim 33 , comprising from about 5% to about 7.5% of the enriched extract.